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    Summary
    EudraCT Number:2007-002611-27
    Sponsor's Protocol Code Number:GAM10-03
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-12-14
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2007-002611-27
    A.3Full title of the trial
    Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID)
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberGAM10-03
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN63491981
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOctapharma AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Octagam 10%
    D.2.1.1.2Name of the Marketing Authorisation holderOctapharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOctagam 10%
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGAM10
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Immundeficiency Diseases (PID)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064859
    E.1.2Term Primary immunodeficiency syndrome
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to investigate the safety of Octagam® 10% in
    replacement therapy in PID and to compare the pharmacokinetic profile of Octagam® 10%with that of the previously used commercial Octagam® 5% (Pharmacokinetic sub-study).
    Safety outcome parameters will be:
    • Occurrence of adverse events.
    • Short term tolerance parameters including vital signs (blood pressure, heart rate,
    temperature, respiratory rate).
    • Laboratory parameters (hematology, clinical chemistry, direct Coombs’test,
    urinalysis) and tests for viral safety.
    Pharmacokinetic outcome parameters will be the parameter Cmax, Cmin, t ½, Tmax, AUC, volume of distribution, and incremental recovery of serum total IgG; of IgG subclasses (IgG1, IgG2, IgG3, IgG4); of specific antibodies against Haemophilus influenzae, Streptococcus pneumoniae (types 4, 6B, 9V, 14, 18C, 19F, 23F), CMV, VZV, tetanus, measles; and of glucose and maltose.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to investigate the efficacy of Octagam® 10% in replacement therapy in PID by monitoring the rate of occurrence of serious bacterial infections, the rate of other infections, the trough (pre-next-dose) levels of total serum IgG and IgG subclasses (IgG1, IgG2, IgG3, IgG4), the trough (pre-next-dose) levels of selected antigen specific antibodies, use of antibiotics, rate of absence from work/school, number and days of hospitalizations.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    • Age of ≥ 2 years and ≤ 75 years.
    • For minor patients, above a minimum weight based on the amount of blood
    required for testing: per individual, the trial-related blood loss (including any
    losses in the manoeuvre) should not exceed 3% of the total blood volume during a
    period of four weeks and should not exceed 1% at any single time (the total
    volume of blood is estimated at 80 ml/kg body weight).
    • Confirmed diagnosis of primary immunodeficiency as stated by the World Health
    Organisation and requiring immunoglobulin replacement therapy due to hypogammaglobulinemia or agammaglobulinemia. The exact type
    of PID should be recorded.
    • Previously treated with commercial Octagam 5% every 21-28 days for at least 6 infusion intervals at a constant dose between 200-800 mg/kg body weight
    • Availability of the IgG trough levels of the two previous infusions before enrollment, and maintenance of at least 5.5 g/L in the trough levels of these two
    infusions.
    • Negative result on a pregnancy test (HCG-based assay in blood or urine) forwomen of child-bearing potential and use of a reliable method of contraception for
    the duration of the study.
    • For adult patients: freely given written informed consent. For minor patients:
    freely given written informed consent from both parents/legal guardians and
    written informed assent from the child/adolescent ≥ 8 years of age, according to
    his/her age and capacity of understanding.
    • Willingness to comply with all aspects of the protocol, including blood sampling,
    for the duration of the study
    E.4Principal exclusion criteria
    Exclusion criteria:
    • Acute infection requiring intravenous antibiotic treatment within two weeks before
    screening.
    • Known history of adverse reactions to IgA in other products.
    • Exposure to blood or any blood product or derivative, other than a commercially
    available Octagam 5%, within the past 3
    months.
    • Ongoing history of hypersensitivity or persistent reactions to blood or plasma
    derived products, or any component of the investigational product, such as
    maltose.
    • Requirement of any routine pre-medication for IGIV infusion.
    • History of congenital impairment of pulmonary function.
    • Severe liver function impairment (ALAT 3x > normal value)
    • Severe renal function impairment (creatinine > 120 μmol/L), or predisposition for
    acute renal failure (e.g. any degree of pre-existing renal insufficiency or routine
    treatment with known nephritic drugs).
    • History of autoimmune haemolytic anemia.
    • History of diabetes mellitus.
    • Congestive heart failure NYHA III or IV.
    • None-controlled arterial hypertension (systolic blood pressure > 160 mm Hg
    and/or diastolic blood pressure > 90 mm Hg).
    • History of DVT or thrombotic complications of IGIV therapy.
    • Known to be infected with HIV, HCV or HBV.
    • Presence of any clinically relevant disease or unstable condition beside those
    concerning study indication at screening which in the opinion of the investigator
    may interfere with the conduct of the study.
    • Treatment with steroids, immunosuppressive or immunomodulatory drugs.
    • Planned vaccination during the study period.
    • Treatment with any investigational agent within the prior 3 months.
    • Known or suspected to abuse alcohol, drugs, psychotropic agents or other
    chemicals within the last 12 months.
    • Pregnant and/or nursing women.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is the rate of Octagam® 10% infusions with one or more adverse
    events occurring during or within 72 hours after end of the infusion, including adverse events that are determined not to be product-related.
    Second primary endpoint is the comparison of the pharmacokinetic profile of
    Octagam® 10% with that of the previously used commercial Octagam® 5%.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The clinical end of the study is defined as the date when the last study patient completes the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children and adolescents
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 45
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The normal treatment of the patient already applied before study entry will be started again after study end.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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